Saturday, May 28, 2016 10:43:37 AM
Sarepta new IND is a very special case for an Orphan Disease that there is no SOC.
As of May 26,2016
The 12 patients is simply not enough persons to draw conclusions. The ADCOM and the FDA have voted again to request more data with a second delay on this new molecule.
However absolutely no comparison to $ELTP SequestOx delivery system of Agonist and Antagonist where over the past 2 years,the 40 person HAL and 163 Person P3 bunionectomy were as directed by the FDA. Remember it is SequestOx delivery system on trial and not the Oxycodone and Naltrexone which are well known for many years. There are ZERO new molecules on trial.
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